Kornimate/medical-research-clean huggingface dataset:
anastomotic leak in covid-19

Conditions: Anastomosis, Leaking

Summary: evaluate the incidence of anastomotic leak after colorectal surgery


Eligibility criteria:
inclusion criteria: * colorectal cancer exclusion criteria: * stage 4
the primavera study: reduxine safety monitoring in patients with alimentary obesity

Conditions: Alimentary Obesity

Summary: the aim of this study is to summarize the data on efficacy and safety of reduxine administration in the routine clinical practice according to the approved indications.

secondary objectives: * to study the structure of the population of patients with the diet induced obesity with body mass index (bmi) 30 kg/m2 or diet induced obesity with bmi ≥27 kg/m2 associated with type 2 diabetes mellitus in respect of comorbidities and concomitant treatment to determine the areas for further investigations. * to introduce the elements of control of adverse cardiovascular risks into the routine clinical practice: questionnaire concerning enrollment criteria for reduxine treatment initiation, algorithm of reduxine administration and treatment efficacy and safety monitoring (assessment schedule). * to assess the effects of the treatment of overweight and obesity with reduxine on patients' quality of life parameters. the time frame: the follow up of the study patients will be performed during six month to one year. exception - premature discontinuation from the study. the scheduled visits of the patients to the investigational centres are: week0 (inclusion of the patient), week 2, 4, 6, 8, 10, 12, 16, 20, 24, 36 and week 48.

Eligibility criteria:
inclusion criteria: * men and women of 18-65 years of age to whom, in the doctor's opinion, the on-label use of reduxine is indicated. * patient's desire and ability to participate in the program and fulfill the doctor's instructions designed to achieve the treatment goal and the program requirements compliance. * signed informed consent form for participation in the program. exclusion criteria: - patients under age of 18 or older than 65; current or the history of: * coronary artery disease (e.g. angina, myocardial infraction); * congestive heart failure; * tachycardia; * peripheral arterial occlusive disease; * arrythmia; * uncontrolled arterial hypertension \>145/90 mm hg; * hypersensitivity to sibutramine or any components of reduxine®; * current use of monoamineoxidase inhibitors (imao) or their use within the last 2 weeks; * current use of other central acting weight reducing drugs or their use within the last 2 weeks; * use on other drugs affecting the central nervous system (e.g. antidepressants, neuroleptics); tryptophan-containing drugs indicated for sleep disturbance; * severe eating disorder (anorexia nervosa or bulimia); * mental disease; * gilles de la tourette syndrome (generalized tics); * body mass index ≤30 kg/m2 or ≤27 kg/m2 in the presence of concomitant diseases (dyslipidemia, diabetes); * organic cause of obesity (e.g. hypothyrosis); * thyrotoxicosis; * sever liver and/or kidney function abnormality; * benign prostatic hyperplasia; * phaeochromocytoma; * narrowangle glaucoma; * documented pharmacologic, drug or alcohol addiction; * pregnancy and lactation; * refusal to sign the informed consent form for participation in the program; * participation in a clinical study of any new drug product within 90 days prior to the screening visit.
evaluation of the ib10 sphingotest pct+ in a point-of-care setting

Conditions: Sepsis

Summary: to establish the equivalence of ib10 sphingotest pct+ measurements in point-of-care settings such as emergency rooms or intensive care units, with corresponding procalcitonin measurements obtained in a reference or clinical laboratory using a comparative assay, with respect to the same subset of human edta plasma specimens.


Eligibility criteria:
inclusion criteria: * subject is able and willing to provide written informed consent * subject is 18 years of age or older * subject is presenting with symptoms suggestive of bacterial infection * subject is presenting with two or more of the following symptoms suggestive of systemic inflammatory response syndrome (sirs): * body temperature less than 36°c (96.8°f) or greater than 38°c (100.4°f); * heart rate greater than 90 beats per minute; * respiratory rate greater than 20 breaths per minute, or an arterial partial pressure of carbon dioxide (pco2) less than 4.3 kpa (32 mmhg); * white blood cell count less than 4,000 cells/mm3 (4 x 109 cells/l) or greater than 12,000 cells/mm3 (12 x 109 cells/l); * a normal white blood cell count with the presence of greater * than 10% immature neutrophils. exclusion criteria: * subjects less than 18 years of age; * subjects who do not present with a minimum of two symptoms suggestive of sirs, as defined above * subjects unable or unwilling to provide written informed consent
negative serology by immunoenzymatic test (eia) in hiv-infected children treated early with antiretroviral in the anrs-pediacam study: pathophysiological mechanisms

Conditions: HIV Infections

Summary: the objective of the study is to identify the pathophysiological mechanisms responsible for the induction and maintenance of negative serologies by eia tests in hiv-infected children treated early with haart in the anrs 12225-pediacam iii cohort in cameroon the hypothesis of better control of hiv infection through interactions between immunological, viral, and genetic factors was made to build the following objectives: * immunological aspect: lack of humoral response or immune activation * virological aspect: reduced hiv reservoir size * determine the hla phenotype in the different groups of children included and the kir genotypes.

there will be two phases of the study : * a retrospective phase: case-control study the analyzed data are those collected previously or measured from the already available bio bank, within the framework of the pediacam iii cohort during the primary infection phase before the initiation of haart, at 6 months after the end of the first series of epi vaccines, and at 2 years. * a prospective phase: cross-sectional study based on an ad hoc bio bank created for parameters we couldn't measure on the existing bio bank

Eligibility criteria:
inclusion criteria: case control study * children included and followed in the anrs 12225 study - pediacam iii * having plasma samples in the bio bank during the above-mentioned periods case:children with at least one negative hiv serology made by elisa, permanent or transientduring follow-up. control (4 groups) * hiv-infected children with positive serology and viral load (vl) \<400 copies /ml * hiv-infected children with positive serology and vl ≥400 copies / ml * hiv-uninfected children born to hiv-positive mothers * hiv-uninfected children born to hiv-uninfected mothers selection of cases and controls will be matched on gestational age (premature \<37, term ≥37 weeks) and year of birth (2007-2008 and 2009-2010). cross sectional study inclusion criteria * all children still followed in the anrs - pediacam iii cohort * written consent of one of the parents or the guardian and assent of the child if aged ≥ 11 years and complete disclosure of hiv statusfor infected children for participation to the study. exclusion criteria: * refusal by one of the parents or the guardian for the child's participation in the study * no assent of the child (if aged ≥ 11 years and with complete disclosure of hiv status, for infected children)
water method colonoscopy in patients with prior surgery

Conditions: Intubation; Surgery; Adenoma; Pain

Summary: water method with water exchange has been shown to reduce medication requirement and pain experienced during colonoscopy. it increases the success rate of cecal intubation in sedated and unsedated patients undergoing screening colonoscopy. exchange of water during scope insertion minimizes distension of the colonic lumen and decreases loop formation. exclusion of air from the colon during insertion by omission of air insufflations and suction removal of residual air prevent elongation of the colon. these maneuvers facilitate colonoscopy insertion in average patients and may enhance the success of difficult colonoscopy. prior abdominal or pelvic surgery is an independent factor for difficult colonoscopy, the probable adhesion may change the anatomy and increase the discomfort of patients. we postulate that these patients may benefit from using the water method for colonoscopy. in this proposal we test the hypothesis that compared with conventional air insufflations the water method with water exchange significantly enhances the success rate of cecal intubation in patients with prior abdominal or pelvic surgery. the aim of the study is to compare the outcome of colonoscopy using the water method versus the conventional air method in patients with prior abdominal or pelvic surgery. the primary outcome is cecal intubation success rate. the secondary outcomes include cecal intubation time, maximum pain score during colonoscopy, overall pain score after colonoscopy and adenoma detection rate.


Eligibility criteria:
inclusion criteria: * patients with prior abdominal or pelvic surgery, exclusion criteria: * history of colorectal surgery * severe colonic stricture or obstructing tumor * patients who cannot give informed consent and those who are hemodynamically unstable

Keywords: colonoscopy water surgery unsedated
comparison of different glucose concentrations in dialysate of hemodialysis patients

Conditions: Hemodialysis; ESRD

Summary: this study aims to show that using a glucose (sugar) concentration of 100 mg/dl in the dialysis fluid for hemodialysis is not inferior to using a concentration of 200 mg/dl with regard to the frequency and magnitude of blood glucose drops. other parameters that will be compared between the two groups are blood pressure, heart rhythm, weight gain between dialysis treatments, and fatigue after the treatment.

this is a prospective, randomized, single-blinded cross-over non-inferiority trial of intra- and early post-dialytic glucose homeostasis comparing 100 mg/dl against 200 mg/dl dialysate glucose concentration in 30 hemodialysis patients. the primary outcome is the frequency and magnitude of hypoglycemia during and early after the hemodialysis treatment. secondary outcomes include intradialytic blood pressure, interdialytic weight gain, serum potassium and phosphorus concentrations, arrhythmias during dialysis and in the early postdialytic period, and postdialytic fatigue. inclusion criteria: age ≥ 18 years maintenance hemodialysis with hemodialysis vintage of at least 30 days ability to read and understand the english language and give informed consent exclusion criteria: dialysis treatment frequencies other than three times per week hospitalizations or antibiotics-dependent infection during the 8 weeks preceding enrollment central venous catheter as hemodialysis access

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * maintenance hemodialysis with hemodialysis vintage of at least 30 days * ability to read and understand the english language and give informed consent exclusion criteria: * dialysis treatment frequencies other than three times per week * hospitalisations or antibiotics-dependent infection during the 8 weeks preceding enrollment * central venous catheter as hemodialysis access

Keywords: hemodialysis esrd
intradermal bont-a treatment in erythematotelangiectatic rosacea

Conditions: Erythematotelangiectatic Rosacea

Summary: investigation of the effectiveness of intradermal botulinum toxin a treatment in the treatment of erythematotelangiectatic rosacea (etr) using clinical, biophysical, dermatoscopic and videocapillaroscopy.

there is no gold standard treatment for erythematotelangiectatic rosacea (etr). in recent years, some studies have been conducted to demonstrate the efficacy of intradermal botulinum toxin a (bont-a) treatment in etr and facial erythema. studies including objective and quantitative measurements are limited. this study aims to investigate the efficacy and safety of intradermal bont-a treatment in etr patients. this randomised, double-blind, split-face study included 30 participants with erythematotelangiectatic rosacea (etr). they were randomly randomised to intradermal bont-a on one side of the face and placebo on the other side. clinician's erythema assessment (cea) score, patient self-assessment (psa) score, erythema index (ei), melanin index (mi), dermatoscopic and capillaroscopic analyses of background erythema and vascular structure were assessed at baseline and one month after treatment.

Eligibility criteria:
inclusion criteria: * 18-60 years old * erythematotelangiectatic rosacea subtype * willingness to participate in the research and providing informed consent exclusion criteria: * patients under 18 years of age, over 60 years of age * a rosacea subtype other than etr * history of using topical or systemic medications within the past two weeks due to rosacea or other dermatoses * known history of autoimmune disease * history of neuromuscular disease * history of facial botulinum toxin injection within the last six months * reporting allergy to the active ingredient * pregnant or breastfeeding patients * patients who do not accept treatment and follow-up
iron status, maternal depressive symptoms, and mother-child interactions

Conditions: Iron Deficiency Anemia

Summary: this study aims to examine the relation between iron status and maternal-child interactions as well as maternal depressive symptoms in mothers from central pennsylvania.

investigators aim to follow mothers and their infants from 6 weeks to 6 months in the postpartum to understand the relation between iron status and mother-child interactions and depressive symptoms. during this period, iron deficient anemic mothers will receive an intervention with iron with the scope of improving iron status, reducing their depressive symptoms, and in turn, increasing the quality of parenting behaviors during mother-child interactions. the control group will be iron sufficient mothers who will receive a placebo.

Eligibility criteria:
inclusion criteria: 1. pregnant women between 18 - 40 years. 2. mother expects to be the primary caregiver for the infant for study duration and will allow infant to be enrolled in the study.. 3. mother has no history of gastrointestinal or hematological disorders and not taking medications that interfere with hematopoiesis or absorption. 4. after birth, the mother and baby are healthy, delivery was of one infant only, infant gestational age ≥ 38 weeks, infant weight ≥ 2500 g (5.5 lbs), neither the mom nor the infant received a blood transfusion at or since delivery, and mom agrees to discontinue use of any iron containing medications. exclusion criteria: 1. maternal age ≤ 18 and \> 40 years 2. evidence of a history of gastrointestinal or hematological disorders and evidence of taking medications that interfere with hematopoiesis or absorption. 3. severely anemic (hemoglobin \< 90 g/l) 4. iron deficient but not anemic women 5. non-english speaking

Keywords: iron deficiency anemia (ida) iron status mother-infant interactions intervention study postpartum depressive symptoms
effect of experience sharing and mutual assistance on insight and recovery during the first psychotic episode

Conditions: Psychotic Episode

Summary: controlled, prospective, qualitative and quantitative trial. the goal of this trial is to evaluate the mutual assistance early intervention device efficacy and its impact on insight and personal recovery of participants living with a first psychotic episode. this intervention lasts 5 days with 1 session per day of 1 hour 30 minutes. three evaluations, before the intervention, after intervention and 1 month after the hospitalization's end.


Eligibility criteria:
inclusion criteria: * man or woman between 18 and 40 years old * first psychotic episode under the guidance of a doctor * brief psycotic trouble (sm-v) * presenting a first psychiatry hospitalization (all modalities hospitalizations combined) * fluent in french language (read and written) * patient affiliated to a social protection system or beneficiary of medical aid of state * patient having signed informed consent for his participation in the protocol exclusion criteria: * patients whose clinical condition does not allow them to participate in research * patients placed in isolation rooms during the intervention

Keywords: retablishment insight mutual assistance peer helper psychiatric hospitalization first psychotic episode
exercise interventions in post-acute sequelae of covid-19

Conditions: COVID-19

Summary: the covid-19 pandemic severely impacted the medical system both directly but also through incomplete recovery from the virus in the form of post-acute sequelae of covid-19 (pasc). pasc affects at least 9.6 million individuals as of may 2022 and continues to affect many more. pasc is a multisystem disorder often presenting with mental fog, dyspnea on exertion, and fatigue among other symptoms. the etiology of pasc is uncertain but theories include direct cytotoxicity, dysregulated immune responses, endotheliitis associated with microthrombi, enos uncoupling, and myocardial fibrosis with impaired ventricular compliance. to date, there are no established treatments. exercise has the potential as a therapeutic option to improve vo2peak and improve each of the aforementioned underlying etiologies. the investigators plan to examine the effect of high-intensity interval training (hiit) and moderate intensity exercise training (mod) on the symptoms and exercise tolerance of patients with pasc. the investigators approach will consist of a randomized, blinded, 2-arm, parallel-group design. enrolled subjects will be randomly assigned to one of two groups in a 1:1 allocation ratio. all groups will undergo a 4-week intervention of 3 days of hiit per week and 2 days of mod per week or control of light stretching and controlled breathing. subjects will be assessed before and after the 4-week intervention to examine the extent to which 4 weeks of the hiit and mod combination improves vo2peak and left ventricular diastolic function, global longitudinal strain (gls), and global circumferential strain (gcs). further, the investigators will explore changes in markers such as heart rate, heart rhythm, blood pressure, quality of life, exercise tolerance, and pasc symptoms as well as blood/serum markers.


Eligibility criteria:
inclusion criteria: * 18-50 years of age * diagnosed with post acute sequelae of covid-19 * physician clearance to undergo exercise training (see section titled cardiorespiratory fitness testing for details; page 6) * complete covid-19 vaccination status exclusion criteria: * unstable angina or myocardial infarction in the past 4 weeks * uncompensated heart failure * nyha class iv symptoms * complex ventricular arrhythmias * musculoskeletal contraindications to stationary bicycling exercise * symptomatic severe aortic stenosis * acute pulmonary embolus * acute myocarditis * uncontrolled hypertension as defined as systolic blood pressure \> 180 mm hg or diastolic blood pressure \> 120 mm hg * medication non-compliance * pregnant women-self reported * copd gold stage d * malignancy currently actively being treated * uncontrolled asthma * uncompensated cirrhosis of the liver * chronic kidney disease requiring dialysis therapy * symptomatic anemia * hemoglobin \<7g/dl * poorly controlled diabetes or a1c\>9% * bmi \>35kg/m2 * pulmonary hypertension stage iv * any condition requiring supplemental oxygen * multiple sclerosis
levetiracetam to prevent post-traumatic epilepsy

Conditions: Epilepsy; Post-traumatic Epilepsy

Summary: head injury is the cause of approximately 5% of all epilepsy in the us. past attempts at preventing epilepsy by treatment with older antiepileptic drugs have been unsuccessful. levetiracetam is a novel aed with potent antiepileptogenic properties in animal models of epilepsy. it has a favorable side effect and pharmacokinetic profile. it is therefore a strong candidate for a clinical trial of epilepsy prevention following traumatic brain injury (tbi). however, there has been no experience in administering levetiracetam rapidly to individuals with acute tbi. the investigators propose to initiate the evaluation of levetiracetam in prevention of post-traumatic epilepsy by determining the safety, tolerability, pharmacokinetics and feasibility of acute and chronic administration of levetiracetam to individuals with head injury with a high risk for developing post-traumatic epilepsy. further, the investigators will follow subjects for 2 years after injury in order to obtain pilot data about effect of levetiracetam on pte. this pilot study is the first step in evaluation of levetiracetam in prevention of post-traumatic epilepsy.


Eligibility criteria:
inclusion criteria: * acute head injury associated with one of the following: intracranial hemorrhage, including epidural, subdural and intracerebral hemorrhage or with cerebral contusion(s) of any size; penetrating (foreign body) head injury; skull fracture and dural tear; seizure within 8 hours of head injury * onset of head injury within 8-hours of proposed treatment initiation. * glasgow coma scale 6-15. exclusion criteria: * clinical contraindications: * previous epilepsy or status epilepticus. * any systemic illness or unstable medical condition that might pose additional risk, including: renal insufficiency, other unstable metabolic or endocrine disturbances, and active systemic cancer. * psychosis within six months of enrollment as determined by history of hospitalization for psychosis or medications for psychosis. * moderate to severe mental retardation (iq\ 2 school grade levels below the expected for age \[expected age = grade level +5\]). * clinical/laboratory indicators: * serum creatinine \> 1.5 on the day of treatment initiation for adults. * serum creatinine ≥1.5 for subjects ≥17 years old, ≥1.0 for subjects 13-17 years old and ≥0.7 for subjects 6-12 years old. * pregnancy * use of any cns-active investigational drugs within 3 months of enrollment. * use of antiepileptic drugs (aeds) within two months of enrollment, for any indication. * allergy/sensitivity to study drugs or their formulations: * active drug or alcohol dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements: * inability or unwillingness of subject or legal guardian/representative to give written informed consent.

Keywords: post-traumatic epilepsy traumatic brain injury epilepsy prevention levetiracetam